Rolnictwo i żywność · 3.12.2024
Submission for OMB Review; Comment Request
In 1986, the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) was published by the Office of Science and Technology Policy and explained the regulatory roles for the U.S. Department of Agriculture, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA), (herein, the Agencies) and how Federal agencies use existing Federal statutes to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework was subsequently updated in 1992 (57 FR 6753-6762; February 27, 1992) and 2017, taking into account advances that had occurred in the field of biotechnology. Within the USDA, the Animal and Plant Health Inspection Service's (APHIS') Biotechnology Regulatory Services unit is responsible for ensuring that organisms developed using genetic engineering, such as genetically modified plants, insects, and microbes do not pose a plant pest risk. APHIS derives its authority to promulgate its biotechnology regulations from provisions of the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) and the Virus-Serum-Toxin Act (